Control Change. Ensure Compliance.
Automate and track every change with QT9’s Change Control Module, built to streamline approvals, reduce risk and meet ISO and FDA standards.
Standardize Change Steps
Ensure consistent, repeatable change processes across teams.
Track Every Change
Maintain a complete audit trail for compliance & accountability.
Speed Approvals
Automate routing and sign-offs to avoid bottlenecks.
Strengthen Compliance
Align with ISO, FDA, EU and GxP change control requirements.
Reduce Manual Errors
Eliminate spreadsheets and streamline workflows.
Boost Cross-Team Visibility
Keep stakeholders informed with real-time status updates.
What is change control software?
Change control software is used to manage how organizations propose, assess, approve and implement changes to processes, documents, equipment or systems. It plays a critical role in maintaining compliance with quality standards, such as ISO 9001, FDA 21 CFR Part 820 and GMP, by ensuring changes are documented, evaluated and controlled.
QT9’s Change Control software streamlines the entire change process, with automated workflows, approval routings, risk assessments and traceability. The Change Control module works in conjunction with the rest of QT9 QMS to reduce delays, improve visibility and maintain audit readiness for regulated industries.
All-in-one solution for simplified change control
Seamlessly link to document control, deviations and corrective actions to ensure appropriate control.
Link Processes
Link change control records to processes and departments.
Document Control
Fully integrate with document control module.
Real-Time Reporting
Data mining and trend analysis using real-time data.
Deviations & CAPAs
Create deviations and corrective actions directly from Change Control module.
Improve Participation
Use Change Control tasks to get more people involved on any change control project.
User-Defined Fields
Create unlimited user-defined fields for tracking company-specific information.
Email Alerts
Configure email alerts for due dates and approval processes.
Unlimited Attachments
Attach unlimited files to any change control record.
Change History
See the history of change control records.
Types & Categories
Bulk Approvals
Task Assignment
Get end-to-end quality management
FAQ: Change Control
Change control is a process used to manage changes to a product, organizational structure, process, equipment, input or methodology so that changes are introduced and controlled in a coordinated manner. The goals of change control procedures are to ensure thorough evaluation and documentation of the change’s necessity, impacts and implementation so that there is minimal disruption to services and a cost-effective use of resources.
The goal of a quality management system is to ensure the ongoing quality and safety of your products and services. Any changes that occur in the process of creating these products and services must be thoroughly evaluated and documented to ensure their integrity and to meet regulatory requirements that hold organizations to these standards.
Both the International Organization for Standardization (ISO), GMP, and the U.S. Food and Drug Administration (FDA) discuss methods for managing change control in their regulatory requirements.
ISO 9001 and ISO 13485 require an organization to have plans in place to manage the change process, review the consequences of unintended changes and prevent or mitigate any adverse effects. GMP guidelines state, “Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated.”
FDA 21 CFR Parts 210, 211 and 820 all require manufacturers to establish and maintain procedures for the identification, documentation, validation, verification, review, and approval of design and manufacturing changes. In addition, any changes to documents require review and approval by a qualified monitor, and communication of changes to stakeholders in a timely manner.
While the goals of change control and project management differ, the basic approach to each is very similar – initiate, analyze, plan, execute, close. Change control, however, looks to manage the process of change and predict how it may affect already established systems. Project management is tasked with ushering a team or product from Point A to Point B until the project’s goal is completed.
QT9 incorporates a robust change control application into its eQMS. The module is able to integrate with related applications, such as corrective actions, deviations, and document control.
QT9 QMS is a total quality solution available at an accessible price point, with 25-plus standard modules that help simplify and centralize quality and compliance. Plus QT9 offers full customer support, an ERP integration and a Business Intelligence tool to help visualize and make informed decisions in real time.
Change control resources
Change Management in Life Sciences and Medical Devices
Navigating Change Using Change Control Software
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